HEALTH-RELATED QUALITY OF LIFE IN CEREBRAL PALSY: AGREEMENT BETWEEN ADOLESCENTS, CAREGIVERS AND PHYSIOTHERAPISTS

NCT07211594 | Completed

• 1 other identifier: GO 18/876-02
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Health-related quality of life (HRQoL) has recently become a widely used outcome measure. Although self-reporting is considered the gold standard, proxy reports are commonly used for adolescents with cerebral palsy (CP). Study Question: Is there agreement between adolescents, caregivers and physiotherapists in health-related quality of life reports in adolescents with cerebral palsy?

Conditions

Health-Related Quality-of-Life; Adolescent; Cerebral Palsy (CP)

Keywords

health-related quality of life; cerebral palsy (CP); adolescent

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life: The Pediatric Quality of Life Inventory (PedsQL) Measurement Tool

  PedsQL was designed to evaluate HR-QOL in generic and disease-specific situations with disease-specific modules in children and adolescents between 2-18 years old. The PedsQL 3.0 CP Module was designed to measure HR-QOL dimensions specific to CP. PedsQL 3.0 CP encompasses 35-item in Module seven scales: (1) Daily Activities (9 items); (2) School Activities (4 items); (3) Movement and Balance (5 items); (4) Pain and Hurt (4 items); (5) Fatigue (4 items); (6) Eating Activities (5 items); and (7) Speech and Communication (4 items). The Scales are included in parallel adolescent self-report and parent proxy-report formats. A 5-point Likert scale is used across adolescent self-reports for ages 8 to 18 years and parent proxy reports (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem). Items are reverse scored and transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) so that higher scores indicate better HRQOL.

  5-10 minutes

Study Arms (3)

Adolescents with cerebral palsy

The study was conducted with 97 adolescents CP attending Hacettepe University Physiotherapy and Rehabilitation Department's Pediatric Rehabilitation together with their caregivers.

Caregivers of adolescent with cerebral palsy

Caregivers of adolescent with cerebral palsy who may be parents, grandparents or caregivers.

the physiotherapist who conducts the adolescent rehabilitation process.

pediatric physiotherapists working in the field of pediatric rehabilitation especially with cerebral palsy

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The demographic information such as weight, height, sex, age etc. were recorded for adolescents, as well as the age and educational status of the caregivers. Gross Motor Function Classification System (GMFCS-E\&R) were used to classify the adolescents' gross motor function. The hand function of adolescents in daily activities was classified with The Manual Ability Classification System (MACS), and the communication of adolescents was classified with the Communication Function Classification System (CFCS). Clinicians and researchers used these classification systems to grade functional capacity systems and constitute a common language to describe function.

You may qualify if:

• being diagnosed with CP of all clinical types,
• aged 11-18 years,
• who can understand and answer the questions.

You may not qualify if:

• Adolescents who did not attend regular therapy sessions
• Physiotherapists who performed therapy sessions with the adolescent for less than four weeks

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• Sentenac M, Rapp M, Ehlinger V, Colver A, Thyen U, Arnaud C. Disparity of child/parent-reported quality of life in cerebral palsy persists into adolescence. Dev Med Child Neurol. 2021 Jan;63(1):68-74. doi: 10.1111/dmcn.14638. Epub 2020 Jul 25.

  PMID: 32710687 BACKGROUND

• Morrow AM, Hayen A, Quine S, Scheinberg A, Craig JC. A comparison of doctors', parents' and children's reports of health states and health-related quality of life in children with chronic conditions. Child Care Health Dev. 2012 Mar;38(2):186-95. doi: 10.1111/j.1365-2214.2011.01240.x. Epub 2011 Jun 8.

  PMID: 21651605 BACKGROUND

• Aza A, Riquelme I, Gomez Vela M, Badia M. Proxy- and self-report evaluation of quality of life in cerebral palsy: Using Spanish version of CPQOL for Children and adolescents. Res Dev Disabil. 2024 Nov;154:104844. doi: 10.1016/j.ridd.2024.104844. Epub 2024 Sep 24.

  PMID: 39321691 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mintaze Kerem Gunel, Prof. Dr.

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: October 18, 2018
• Primary Completion: May 18, 2019
• Study Completion: February 18, 2020
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)